Day

December 23, 1997
Failure to validate the finished device testing software for the ProNeb and Duraneb 2000 compressors and complaint handling software according to established protocols; failure to establish written procedures for monitoring and control of process parameters; failure to establish written procedures and to develop specifications for the contract manufacturer; and failure to establish final acceptance procedures....
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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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